如何阐释医学数据的免同意研究使用:“健康数据素养”之实例
How to Elucidate Consent-Free Research Use of Medical Data: A Case for "Health Data Literacy".
作者信息
Richter Gesine, Krawczak Michael
机构信息
Institute of Experimental Medicine, Division of Biomedical Ethics, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.
German Center for Lung Research (DZL), Airway Research Center North (ARCN), Borstel, Germany.
出版信息
JMIR Med Inform. 2024 Jun 18;12:e51350. doi: 10.2196/51350.
The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and risk of consequent methodological problems in the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by sharing personal health data, the paradigm of informed consent needs to be reconsidered. The European General Data Protection Regulation gives the European member states considerable leeway with regard to permitting the research use of health data without consent. Following this approach would however require alternative offers of information that compensate for the lack of direct communication with experts during medical care. We therefore introduce the concept of "health data literacy," defined as the capacity to find, understand, and evaluate information about the risks and benefits of the research use of personal health data and to act accordingly. Specifically, health data literacy includes basic knowledge about the goals and methods of data-rich medical research and about the possibilities and limits of data protection. Although the responsibility for developing the necessary resources lies primarily with those directly involved in data-rich medical research, improving health data literacy should ultimately be of concern to everyone interested in the success of this type of research.
个人健康数据的广泛应用是现代医学研究的关键成功因素之一。然而,在临床护理过程中获取使用此类数据的同意,存在批准率低且不平等的风险,以及在数据科学使用中随之产生的方法学问题风险。鉴于这些缺点,以及人们通过分享个人健康数据为医学研究做出贡献的既定意愿,需要重新考虑知情同意的范式。欧洲《通用数据保护条例》在允许未经同意进行健康数据研究使用方面给予欧洲成员国很大的回旋余地。然而,遵循这种方法将需要提供替代信息,以弥补在医疗护理期间缺乏与专家直接沟通的不足。因此,我们引入了“健康数据素养”的概念,定义为查找、理解和评估有关个人健康数据研究使用的风险和益处的信息并据此采取行动的能力。具体而言,健康数据素养包括有关数据丰富的医学研究的目标和方法以及数据保护的可能性和限制的基本知识。虽然开发必要资源的责任主要在于直接参与数据丰富的医学研究的人员,但提高健康数据素养最终应该是所有关注此类研究成功的人所关心的问题。
相似文献
JMIR Med Inform. 2024-6-18
JBI Database System Rev Implement Rep. 2015-10
Acta Otorhinolaryngol Ital. 2005-10
Ther Adv Rare Dis. 2021-9-26
Eur J Hum Genet. 2019-1-25
J Empir Res Hum Res Ethics. 2013-7
BMC Health Serv Res. 2008-3-30
引用本文的文献
本文引用的文献
JMIR Med Inform. 2021-7-5
BMC Med Ethics. 2022-6-16
BMC Med Ethics. 2021-12-15
Health Care Anal. 2022-3
J Pak Med Assoc. 2020-5
J Med Ethics. 2020-5-18
PLoS One. 2019-11-20